As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more
3/16/2020
/ Biotechnology ,
Center for Drug Evaluation and Research (CDER) ,
China ,
Clinical Trials ,
Contingency Plans ,
Coronavirus/COVID-19 ,
Crisis Management ,
Food and Drug Administration (FDA) ,
Imports ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Public Health ,
Supply Chain
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will need to develop expertise in evaluating IVD risk and, if working with IVD...more
The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more
The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies.
In recent years, issues involving the integrity of and controls around manufacturing data...more
FDA agrees to allow truthful and non-misleading off-label promotion.
On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....more
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more
8/11/2015
/ Amarin ,
Caronia ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs
New market exclusivity opportunities emerge for pharmaceutical companies.
In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more
FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more